RT Journal Article
SR Electronic
T1 The long-term safety of pirfenidone (PFD) in patients with idiopathic pulmonary fibrosis (IPF)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P3159
VO 40
IS Suppl 56
A1 Valeyre, Dominique
A1 Albera, Carlo
A1 Bradford, Williamson
A1 Costabel, Ulrich
A1 King, Talmadge
A1 Noble, Paul
A1 Sahn, Steven
A1 du Bois, Roland
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P3159.abstract
AB Introduction: PFD is an oral molecule that is approved in Europe and Japan for the treatment of IPF. Long-term safety is being assessed in two open-label (OL) studies in patients with IPF. Objective: Further examine the long-term safety of PFD in patients with IPF.Methods: All patients receiving PFD 2403 mg/d in the CAPACITY studies or one of two ongoing OL studies of PFD in patients with IPF (Studies 002 and 012) were included in the analysis. Study 002 is a compassionate use study in the U.S.; Study 012 is an OL extension study evaluating PFD in patients who completed CAPACITY. Results: A total of 789 patients were included in the analysis. The median duration of exposure to PFD was 2.6 years (range, 1 week–7.7 years); the median daily dose was 2257 mg (range 25–3600). The cumulative total exposure was 2,052 person exposure years (PEY). Consistent with previous studies, almost all patients (99.7%) reported at least one treatment emergent adverse event (AE). Gastrointestinal and skin-related events were the most commonly reported AE's; these were generally mild to moderate and rarely led to treatment discontinuation. AST/ALT elevations (>3 x ULN) occurred in 21/789 (2.7%) patients; the adjusted incidence of AST/ALT elevations was 1.7 per 100 PEY. Conclusions: Analysis of safety data from IPF patients receiving PFD for up to 7.7 years demonstrates that long-term treatment with PFD is safe and generally well tolerated.